Fabric electrode head

ABSTRACT

An electrode head is disclosed that utilizes electrically conductive or dissipative fabric to exchange electrical energy with tissue. This electrode head may be used for any appropriate application, such as a catheter electrode, a return electrode, or the like. Any appropriate function may be provided by this electrode head, such as tissue ablation, tissue mapping, or providing an electrical ground.

CROSS-REFERENCE

This application is a continuation application of U.S. patentapplication Ser. No. 14/076,400, filed 11 Nov. 2013, which is adivisional application of U.S. patent application Ser. No. 11/618,557,filed Dec. 29, 2006, the entire contents of which is incorporated hereinby reference.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The instant invention generally relates to the field of electrodes. Inparticular, the instant invention is directed to a tissue electrode headthat incorporates fabric for exchanging electrical energy with tissue.

b. Background Art

Catheters have been in use for medical procedures of many years.Catheters can be used for medical procedures to examine, diagnose, andtreat while positioned at a specific location within the body that isotherwise inaccessible without more invasive procedures. During theseprocedures a catheter is insetted into a vessel located near the surfaceof a human body and is guided to a specific location within the body forexamination, diagnosis, and treatment. For example, one procedure oftenreferred to as “catheter ablation” utilizes a catheter to convey anelectrical stimulus to a selected location within the human body tocreate tissue necrosis. Another procedure oftentimes referred to as“mapping” utilizes a catheter with sensing electrodes to monitor variousforms of electrical activity in the human body.

In a normal heart, contraction and relaxation of the heart muscle(myocardium) takes place in an organized fashion as electrochemicalsignals pass sequentially through the myocardium from the sinoatrial(SA) node located in the right atrium to the atrialventricular (AV) nodeand then along a well defined route which includes the His-Purkinjesystem into the left and right ventricles. Sometimes abnormal rhythmsoccur in the atrium which are referred to as atrial arrhythmia. Three ofthe most common arrhythmia are ectopic atrial tachycardia, atrialfibrillation, and atrial flutter. Arrhythmia can result in significantpatient discomfort and even death because of a number of associatedproblems, including the following: (1) an irregular heart rate, whichcauses a patient discomfort and anxiety; (2) loss of synchronousatrioventricular contractions which compromises cardiac hemodynamicsresulting in varying levels of congestive heart failure; and (3) stasisof blood flow, which increases the vulnerability to thromboembolism. Itis sometimes difficult to isolate a specific pathological cause for thearrhythmia although it is believed that the principal mechanism is oneor a multitude of stray circuits within the left and/or right atrium.These circuits or stray electrical signals are believed to interferewith the normal electrochemical signals passing from the SA node to theAV node and into the ventricles. Efforts to alleviate these problems inthe past have included significant usage of various drugs. In somecircumstances drug therapy is ineffective and frequently is plagued withside effects such as dizziness, nausea, vision problems, and otherdifficulties.

An increasingly common medical procedure for the treatment of certaintypes of cardiac arrhythmia and atrial arrhythmia involves the ablationof tissue in the heart to cut off the path for stray or improperelectrical signals. Such procedures are performed many times with anablation catheter. Typically, the ablation catheter is inserted in anartery or vein in the leg, neck, or arm of the patient and threaded,sometimes with the aid of a guidewire or introducer, through the vesselsuntil a distal tip of the ablation catheter reaches the desired locationfor the ablation procedure in the heart. The ablation catheters commonlyused to perform these ablation procedures produce lesions andelectrically isolate or render the tissue non-contractile at particularpoints in the cardiac tissue by physical contact of the cardiac tissuewith an electrode of the ablation catheter and application of energy.The lesion partially or completely blocks the stray electrical signalsto lessen or eliminate arrhythmia.

One difficulty in obtaining an adequate ablation lesion usingconventional ablation catheters is the constant movement of the heart,especially when there is an erratic or irregular heart beat. Anotherdifficulty in obtaining an adequate ablation lesion is caused by theinability of conventional catheters to obtain and retain uniform contactwith the cardiac tissue across the entire length of the ablationelectrode surface. Without such continuous and uniform contact, anyablation lesions formed may not be adequate.

It is well known that benefits may be gained by forming lesions intissue if the depth and location of the lesions being formed can becontrolled. In particular, it can be desirable to elevate tissuetemperature to around 50° C. until lesions are formed via coagulationnecrosis, which changes the electrical properties of the tissue. Forexample, when sufficiently deep lesions are formed at specific locationsin cardiac tissue via coagulation necrosis, undesirable ventriculartachycardias and atrial flutter may be lessened or eliminated.“Sufficiently deep” lesions means transmural lesions in some cardiacapplications.

One difficulty encountered with existing ablation catheters is assuranceof adequate tissue contact. Current techniques for creating continuouslinear lesions in endocardial applications include, for example,dragging a conventional catheter on the tissue, using an arrayelectrode, or using pre-formed electrodes. All of these devices compriserigid electrodes that do not always conform to the tissue surface,especially when sharp gradients and undulations are present, such as atthe ostium of the pulmonary vein in the left atrium and the isthmus ofthe right atrium between the inferior vena cava and the tricuspid valve.Consequently, continuous linear lesions can be difficult to achieve.With a rigid catheter, it can be difficult to maintain sufficientcontact pressure until an adequate lesion has been formed. This problemis exacerbated on contoured or trabecular surfaces. If the contactbetween the electrode and the tissue cannot be properly maintained, aquality lesion may not be formed.

There are additional issues relating to some current ablation electrodedesigns. Certain ablation electrodes may char tissue and/or causecoagulation in a very short time, even when being operated in alow-power mode. Ablation electrodes may of course be operated in ahigh-power mode as well. The resulting elevated temperature of theablation electrode itself may also have an adverse effect on theablation electrode. In this regard, at least some ablation electrodesoffer fluid cooling. Relatively high flow rates (e.g., 70 ml per minute)are typically used for these ablation electrodes to provide an effectivecooling. This may be disadvantageous in one or more respects. Moreover,the flow ports are prone to becoming blocked and/or obstructed, which ofcourse has an adverse effect on the ability of the fluid to cool theablation electrode to the desired temperature. In this regard, increasedcontact pressure between the ablation electrode and the target tissuemay be used to increase the potential for realizing an adequateelectrical coupling, but this may increase the potential for flow portblockage and/or obstruction. Reduced contact pressures may reduce thepotential for flow port blockage and/or obstruction, but this maydegrade the electrical coupling between the ablation electrode and thetissue since the cooling fluid exiting the ablation electrode may becomediluted by bodily fluids.

BRIEF SUMMARY OF THE INVENTION

Various aspects of the present invention that will be addressed hereinrelate to a tissue electrode head—an electrode head that is intended toat least electrically interface with tissue (e.g., while in contact withor when spaced from the tissue). Each such tissue electrode head may becharacterized as exchanging electrical energy with the tissue at thedesired time. Generally, the tissue electrode head may be of anyappropriate type. For instance, the tissue electrode head may be in theform of a catheter electrode. Another option is for the tissue electrodehead to be in the form of a ground patch or the like that interfaceswith the patient's skin (e.g., interfaces with an exterior surface ofthe patient). The tissue electrode head may also provide any appropriatefunction or combination of functions. One embodiment has the tissueelectrode head in the form of an active electrode to provide a desiredfunction (e.g., tissue ablation; tissue mapping; electrical energysource). Another embodiment has the tissue electrode head in the form ofa return electrode to provide an electrical ground. The electrode headmay apply electrical energy to a single location (e.g., for spot tissueablation), or may apply electrical energy to tissue while being movedrelative to the tissue (e.g., to create a linear lesion). Furthermore,the tissue electrode head may be of either a “dry” configuration or of a“wet” configuration that provides a flow of an appropriate fluidby/through the electrode head as desired. The various electrode heads tobe described herein also may be appropriate for other types ofelectrodes as well. Finally, each of the following aspects may be usedin combination with one or more of the other aspects.

A first aspect of the present invention is generally directed to atissue electrode head. This electrode head includes a fabric. At leastpart of this fabric is electrically conductive, and may be electricallyinterconnected with an appropriate electrical energy source. When theelectrode head is disposed in an appropriate position relative to apatient, electrical energy may be exchanged with patient tissue via thefabric.

The fabric for the electrode head can be porous. In one embodiment, thefabric has a porosity within a range from being impervious to aparticular fluid used with the electrode head, to providing the fluidwith an unimpeded flow. Fabric porosity may be utilized to achieve adesired flow rate through the electrode head (e.g., for a wet electrodeconfiguration that will be discussed below). Another option is toutilize a fabric porosity that achieves a desired degree of fluidretention. The porosity of the electrode head may also have an impact onthe electrical behavior of the electrode head. The fabric may also becharacterized as being flexible, for instance to provide a desiredinterface with the patient tissue (e.g., undulating and/or curvedsurfaces). In one embodiment, the fabric has a modulus of elasticity ofno more than about that of the target tissue. However, the fabric couldbe incorporated as a rigid structure as well.

Generally, the construction/configuration of the fabric may betailored/engineered to accomplish one or more desired objectives, forinstance to provide a desired electrical field to in turn provide adesired electrical interaction with patient tissue. For instance, insome cases it may be desirable to provide a substantially constantelectrical conductivity along the length of the electrode head. In otherinstances, it may be desirable to provide a graded electricalconductivity along at least a portion of the length of the electrodehead in at least some respect (e.g., a certain length segment may bemore electrically conductive than another length segment). One or moresensors may be incorporated into the electrode head to monitor theperformance of the electrode head in at least some respect (e.g., athermal sensor to monitor the electrode head/patient tissue interfacetemperature; a pressure sensor to monitor the contact between theelectrode head and patient tissue; a fiber optic or ultrasound sensorfor in situ lesion identification and/or characterization).

The fabric for the electrode head may be configured in any appropriatemanner. For instance, the fabric may be in the form of an at leastgenerally flat or planar structure (e.g., for a ground patch or returnelectrode application). The fabric may also be formed into a hollowstructure or shell having a closed distal end. Another option would beto wrap the fabric into an at least generally cylindrical structure. Thefabric may also be in the form of a plurality of cantileveredstructures. Each of these cantilevered structures may be of anyappropriate configuration, for instance flat or planar structures, atleast generally cylindrical structures, or the like. The electrode headalso may be configured to compress or deflect to a degree when broughtinto engagement with patient tissue, or to at least substantially retainits configuration at all times.

The entirety of the fabric may be electrically conductive orelectrically dissipative. Another option is for the fabric to includesome combination of electrically conductive materials (e.g.,electrically conductive materials being those having a conductivity ofat least about 10⁻² S/m (Siemens per meter) in one embodiment),electrically dissipative materials (e.g., electrically dissipativematerials being those having a conductivity of at least about 10⁻⁹ S/min one embodiment), and electrically non-conductive materials (e.g.,electrically non-conductive materials being those having a conductivityof less than about 10⁻⁹ S/m in one embodiment). Any appropriateelectrically conductive material may be used by the fabric, anyappropriate electrically dissipative material may be used by the fabric,and any appropriate electrically non-conductive material may be used bythe fabric. In one embodiment, the electrically non-conductive materialis in the form of a dielectric material.

The fabric may be defined by a plurality of first threads or threadsegments and a plurality of second threads or thread segments, whereeach first thread is electrically conductive or dissipative, and whereeach second thread is electrically non-conductive. In one embodiment,each first thread is defined by a plurality of conductive or dissipativefilaments that are wrapped or twisted together, while each second threadis defined by a plurality of non-conductive filaments that are wrappedor twisted together. In any case, the various first threads and thevarious second threads each may be disposed in orientations or woventogether in a manner that generates a desired electrical field fortransferring electrical energy to patient tissue and/or that providesone or more desired properties for the electrode head. The followingcharacterizations may apply individually or in any combination: 1) theplurality of first threads and the plurality of second threads may bedisposed in different orientations; 2) the plurality of first threadsmay extend at least generally along a length dimension of the tissueelectrode head, or stated another way parallel to a reference axisassociated with a length dimension of the electrode head; 3) theplurality of second threads may be wrapped about a reference axisassociated with a length dimension of the electrode head (e.g., incombination with item number 2); 4) at least some of the second threadsmay extend at least generally along a length dimension of the tissueelectrode head, or stated another way parallel to a reference axisassociated with a length dimension of the tissue electrode head (e.g.,in combination with item number 2); and 5) each of the plurality offirst threads and each of the plurality of second threads may be wrappedabout a reference axis associated with a length dimension of the tissueelectrode head, for instance at different wrap angles.

The fabric may be defined by multiple yarns or yarn segments, where eachyarn is defined by twisting a plurality of threads together along alength dimension of the corresponding yarn. Generally, the featuresdiscussed herein with regard to threads is equally applicable to yarns.In one embodiment, at least one yarn is electrically conductive ordissipative, while at least one yarn is electrically non-conductive. Thefabric may utilize yarns of a common stiffness, or at least one yarnused by the fabric may have a different stiffness than at least oneother yarn used by the fabric. Furthermore, the fabric may utilize yarnshaving the same denier (diameter) and thread count, or at least one yarnused by the fabric may have a different denier (diameter) and/or threadcount compared to at least one other yarn utilized by the fabric. Thedenier and/or thread count of one or more yarns of the fabric may beutilized to control the porosity of the fabric, which in turn may beutilized to affect a flow of fluid through the fabric (e.g., for a “wet”electrode head configuration and as will be discussed below), may beused to establish/affect the electrical behavior of the electrode head,or both.

The electrode head may include a plurality of layers—any appropriatenumber of layers may be utilized. Adjacent layers may be disposed ininterfacing and/or spaced relation. At least one of these layers willinclude a fabric defined by one or more materials that are electricallyconductive or dissipative. In one embodiment, first and second layersare disposed in interfacing relation, where the first layer incorporatesthe fabric. The first layer may be electrically conductive ordissipative, while the second layer may be electrically non-conductive.One embodiment has the first layer (electrically conductive ordissipative) being incorporated by the electrode head so as to bepositioned closer to the patient tissue than the second layer(electrically non-conductive). Another embodiment has the second layer(electrically non-conductive) being incorporated by the electrode headso as to be positioned closer to the patient tissue than the first layer(electrically conductive or dissipative). The second layer may be formedfrom any appropriate material or combination of materials, such as adielectric. Moreover, the second layer may be of any appropriate type,such as a fabric or a non-fabric construction.

The fabric of the electrode head may include multiple segments in thelength dimension, and that have one or more different properties. Forinstance, the fabric may include first and second segments. The firstsegment may be electrically conductive or dissipative, while the secondsegment may be electrically non-conductive. One embodiment has the firstsegment (electrically conductive or dissipative) being disposed distallyrelative to the second segment (electrically non-conductive). The firstsegment may define a distal end or distal tip of the electrode head.Another embodiment has the second segment (electrically non-conductive)being disposed distally relative to the first segment (electricallyconductive or dissipative). The second segment may define a distal endor distal tip of the electrode head.

The electrode head may include a distal end section, where this distalend section includes a plurality of fabric segments that are each in theform of a cantilever (e.g., a structure having a fixed end and a freeend). Each of these fabric segments may be disposed in any appropriateorientation, including relative to each other. In one embodiment, atleast some of the fabric segments are disposed in different orientations(e.g., in non-parallel relation to each other). In another embodiment, aleast some of the fabric segments diverge relative to a reference axisproceeding toward their respective fabric segment distal end (e.g., a“fanned out” configuration). The plurality of fabric segments maycollectively define a splayed configuration for the electrode head aswell.

The tissue electrode head may be of a “dry” configuration or may be of a“wet” configuration. In the latter regard, a flow of an appropriatefluid may be provided past and/or through the electrode head, and whichmay interface with the fabric. As noted above, the fabric may becharacterized as being porous. The porosity of the fabric may have aneffect on the flow of fluid through the electrode head. The fluidflowing through the electrode head in turn may have an effect on theelectrical and/or thermal characteristics of the electrode head. Sincethe electrical and thermal characteristics of the electrode head have aneffect on a lesion formed during RF ablation, the fabric may betailored/engineered to obtain a desired lesion. For instance, it may bedesirable to utilize a higher thread count at a proximal end of theelectrode head (e.g., “proximal” being in a direction of a handle thatmay be associated with the tissue electrode head) compared to a distalend of the electrode head (e.g., “distal” being in a directionproceeding away from a handle that may be associated with the tissueelectrode head). Increasing the thread count should decrease theporosity of the fabric.

Although any appropriate flow rate may be utilized for the case of a wetelectrode configuration, a flow rate of no more than about 30 ml/minutemay be sufficient in at least certain instances to accomplish one ormore objectives based upon the electrode head incorporating fabric.Representative objectives include cooling the electrode head andproviding a desired degree of hydraulic conductivity. For instance, aflow of fluid may be provided past a conductive portion of the electrodehead, and this fluid may then carry the current to the tissue (e.g., toprovide a virtual electrode). This allows the electrode head to utilizea distal end that is electrically non-conductive and/or for the tip ofthe electrode head to be spaced from the patient tissue and still becapable of providing an adequate electrical coupling via the fluid flow.A substantially constant hydraulic conductivity may exist along thelength of the electrode head, or the hydraulic conductivity may begraded along at least a portion of the length of the electrode head(e.g., increasing progressing toward a distal end of the electrodehead). A graded hydraulic conductivity may be achieved by modifying theporosity of the electrode head and/or incorporating an anisotropicallyconductive fabric into the electrode head.

Any appropriate way of providing a fluid flow to/through the electrodehead may be utilized. For instance and as will be discussed in moredetail below, the fabric may be wrapped around what may be characterizedas a core, plug, or mandrel. This core may be porous to allow fluidinjected therein to flow radially outwardly through the fabric. Anotheroption would be to include one or more internal flow channels or thelike in the core and that terminate on an exterior surface of the corethat interfaces with the fabric. The core may be formed from anyappropriate material or combination of materials, may be electricallyconductive, electrically dissipative, or electrically non-conductive,and may be rigid or flexible. It should be appreciated that the core maybe utilized for a dry electrode configuration as well.

A second aspect of the present invention is generally directed to atissue electrode head that incorporates a plurality of electrodesegments. Each of these electrode segments includes a distal tip that isengageable with patient tissue. At least some of these electrodesegments are disposed or are disposable in different orientationsrelative to each other.

The electrode head may be electrically interconnected with anyappropriate electrical energy source (e.g., an RF generator). When theelectrode head is disposed in an appropriate position relative to apatient, electrical energy may be transferred to patient tissue via oneor more of the electrode segments. Although each of the electrodesegments may receive a common electrical signal, such may not berequired in all instances (e.g., some of the electrode segments may notreceive any electrical signal; one or more electrode segments couldreceive one electrical signal, while one or more other electrodesegments could receive a different electrical signal).

At least some of the electrode segments may be in the form of fabric,and in one embodiment each such electrode segment is defined entirely byor at least incorporates fabric. Therefore, relevant portions of thediscussion presented above with regard to the first aspect may beutilized by this second aspect. However, other materials may be utilizedto define the electrode segments as well. Although each electrode may beformed from a common material, in one embodiment at least one of theelectrode segments is formed from one material and at least oneelectrode segment is formed from a different material.

Each of the electrode segments may be in the form of a cantilever—astructure having a fixed end and an oppositely disposed free end (theabove-noted distal tip). At least some of the electrode segments may becharacterized as diverging from each other proceeding toward theirrespective electrode segment distal tip. The plurality of electrodesegments also may be characterized as collectively defining a splayedconfiguration for the electrode head.

The various electrode segments may be characterized as being flexible orbendable. In one embodiment, each electrode segment has a modulus ofelasticity of no more than about that of the target tissue. Althougheach of the electrode segments may be of a common stiffness, one or moreelectrode segments may be of a different stiffness than one or moreother electrode segments. Although the various electrode segments may bedisposed in equally spaced relation, a varying distribution of theelectrode segments may be utilized as well. Stated another way, theelectrode head may include a uniform density of electrode segments or anon-uniform density of electrode segments.

A third aspect of the present invention is generally directed to atissue electrode head that incorporates a plurality of electrodesegments that are disposed in end-to-end relation, and where at leasttwo of these electrode sections have different diameters.

Any appropriate number of electrode segments may be utilized. In oneembodiment, a smaller diameter electrode segment is more distallydisposed than a larger diameter electrode segment. In anotherembodiment, the smallest diameter electrode segment defines a distal endsection of the electrode head, while one or more other larger diameterelectrode segments are more proximally disposed.

The electrical conductivity may differ between two or more of theelectrode segments. One embodiment has the electrical conductivitychange from electrode segment to electrode segment. Further in thisregard, the electrical conductivity may increase on an electrodesegment-by-electrode segment basis proceeding in the direction of thedistal tip of the electrode head. Another embodiment has the mostdistally disposed of the electrode segments being of the highestelectrical conductivity compared to the other electrode segment(s).

One or more of the electrode segments may be electrically conductive orelectrically dissipative, including having each electrode segment beelectrically conductive or dissipative. One or more of the electrodesegments may be electrically non-conductive. At least one conductive ordissipative electrode segment and at least one non-conductive electrodesegment may be utilized. Therefore, the features discussed below inrelation to the fourth aspect may be used by this third aspect as well.Each electrode segment may be formed from any appropriate material orcombination of materials. In one embodiment, at least one electricallyconductive or dissipative electrode segment incorporates electricallyconductive or dissipative fabric, although each of the electrodesegments could incorporate fabric. Therefore, the features discussedabove in relation to the first aspect may be used by this third aspectas well individually or in any combination. The features to be discussedin relation to the fifth, sixth, and seventh aspects may be used by thisthird aspect as well, individually or in any combination.

A fourth aspect of the present invention is generally directed to atissue electrode head that incorporates a plurality of electrodesegments that are disposed in end-to-end relation. At least one of theseelectrode segments is electrically non-conductive, while at least one ofthese electrode segments is electrically conductive or electricallydissipative. At least one of the electrode segments utilizes fabric.

Any appropriate number of electrode segments may be utilized. In oneembodiment, a non-conductive electrode segment is more distally disposedthan a conductive or dissipative electrode segment, including where anon-conductive electrode element defines a distal tip of the electrodehead. In another embodiment, a conductive or dissipative electrodesegment is more distally disposed than a non-conductive electrodesegment, including where this conductive or dissipative electrodeelement defines a distal tip of the electrode head and includes fabric.

Each electrode segment may be formed from any appropriate material orcombination of materials. In one embodiment, at least one electricallyconductive or dissipative electrode segment utilizes electricallyconductive or dissipative fabric, although each of the electrodesegments may utilize fabric. Therefore, the features discussed above inrelation to the first aspect may be used by this fourth aspect as well,individually or in any combination. One or more of the electrodesegments may have a different outer diameter than at least one otherelectrode segment. Therefore, the features discussed above in relationto the third aspect may be used by this fourth aspect as wellindividually or in any combination. The features to be discussed inrelation to the fifth, sixth, and seventh aspects may be used by thefourth aspect as well, individually or in any combination.

A fifth aspect of the present invention is generally directed to atissue electrode head that incorporates a plurality of electrodesegments that are disposed in end-to-end relation. An electricallynon-conductive electrode segment defines a distal tip of the electrodehead, while at least one more proximally disposed electrode segment iselectrically conductive or electrically dissipative. The variousfeatures discussed above in relation to the first, third, and fourthaspects, as well as the sixth and seventh aspects to be discussed below,may be used in relation to this fifth aspect, individually or in anycombination.

A sixth aspect of the present invention is generally directed to atissue electrode head. The electrical conductivity of the electrodehead, the hydraulic conductivity of the electrode head, or both, isdifferent at least at two different locations along a length dimensionof the electrode head. The various features discussed above in relationto the first, third, fourth, and fifth aspects, as well as the seventhaspect to be discussed below, may be used in relation to this sixthaspect, individually or in any combination.

A seventh aspect of the present invention is generally directed to atissue electrode head. The porosity of the electrode head is differentat least at two different locations along a length dimension of theelectrode head. The various features discussed above in relation to thefirst, third, fourth, fifth, and sixth aspects may be used in relationto this seventh aspect, individually or in any combination.

The foregoing and other aspects, features, details, utilities, andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates one embodiment of a catheter electrode system havingan electrode head that incorporates an electricallyconductive/dissipative fabric.

FIG. 1B illustrates another embodiment of a catheter electrode systemhaving an electrode head that incorporates an electricallyconductive/dissipative fabric.

FIG. 1C illustrates one embodiment of a core about which an electricallyconductive/dissipative fabric may be wrapped for an electrode head, andwhich includes a plurality of fluid flowpaths.

FIG. 1D illustrates another embodiment of a catheter electrode systemhaving an electrode head that incorporates an electricallyconductive/dissipative fabric.

FIG. 1E is an enlarged view of the electrode head of FIG. 1D, along withone configuration of a base for providing a fluid to the electrode head.

FIG. 2 is a plan view of one embodiment of a patch electrode thatutilizes an electrically conductive/dissipative fabric.

FIG. 3A illustrates a single layer of an electricallyconductive/dissipative fabric that may be used to define an electrodehead.

FIG. 3B illustrates a pair of layers that may be utilized to define anelectrode head, where at least one of these layers is an electricallyconductive/dissipative fabric.

FIG. 3C illustrates three layers that may be utilized to define anelectrode head, where at least one of these layers is an electricallyconductive/dissipative fabric.

FIG. 3D illustrates one embodiment of fabric that has been formed into ahollow, three-dimensional shape for an electrode head.

FIG. 3E is an end view of an electrically conductive/dissipative fabricthat has been wrapped to define an electrode head.

FIG. 3F is an end view of multiple layers that have been wrapped todefine an electrode head, and where at least one of these layers is anelectrically conductive/dissipative fabric.

FIG. 4 is a perspective view of one embodiment of an electrode systemhaving an electrode head that incorporates an electricallyconductive/dissipative fabric and that also utilizes a plurality ofproximally disposed ring electrode elements.

FIG. 5 is a perspective view of one embodiment of an electrode head thatincorporates an electrically conductive/dissipative fabric and thataccommodates a fluid flow for a wet electrode configuration.

FIG. 6A is a perspective view of one embodiment of an electrode headthat incorporates a plurality of electrically conductive/dissipativethread/yarn segments that extend at least generally along the lengthdimension of the electrode head, along with a plurality of electricallynon-conductive thread/yarn segments that are wrapped about an axis thatcorresponds with a length dimension of the electrode.

FIG. 6B is a variation of the electrode head of FIG. 6A, where theelectrode head utilizes a stepped configuration.

FIG. 7 is a perspective view of another embodiment of an electrode headthat incorporates a plurality of electrically conductive/dissipativethread/yarn segments and electrically non-conductive thread/yarnsegments that each extend at least generally along the length dimensionof the electrode head.

FIG. 8 is a perspective view of another embodiment of an electrode headthat incorporates a plurality of electrically conductive/dissipativethread/yarn segments and electrically non-conductive thread/yarnsegments that are each are wrapped about an axis that corresponds with alength dimension of the electrode head, but at different wrap angles.

FIG. 9A is a perspective view of another embodiment of an electrode headthat incorporates multiple layers that have been wrapped to define anelectrode head, and where at least one of these layers is anelectrically conductive/dissipative fabric.

FIG. 9B is a perspective view of another embodiment of an electrode headthat incorporates multiple, annular layers that define an electrodehead, and where at least one of these annular layers is an electricallyconductive/dissipative fabric.

FIG. 10 is a perspective view of another embodiment of an electrode headthat incorporates an electrically conductive/dissipative fabric thatprovides a graded electrical conductivity.

FIG. 11A is a perspective view of another embodiment of an electrodehead that incorporates an electrically non-conductive distal tip, alongwith a proximally disposed section of an electricallyconductive/dissipative fabric.

FIG. 11B is a perspective view of another embodiment of an electrodehead that incorporates an electrically conductive/dissipative tip thatincorporates an electrically conductive/dissipative fabric, along with aproximally disposed, electrically non-conductive section.

FIG. 12A is a perspective view of another embodiment of an electrodehead that incorporates a plurality of electrode segments that are in theform of cantilevers and that may be defined by an, electricallyconductive/dissipative fabric.

FIG. 12B is an end view of the electrode head of FIG. 12A.

FIG. 12C is an end view of the electrode head of FIG. 12A with analternative configuration for the electrode segments.

FIG. 13 is a perspective view of another embodiment of an electrode headthat incorporates an electrically conductive/dissipative fabric and aplurality of sensors.

DETAILED DESCRIPTION

Various embodiments of electrodes that utilize at least one fabricsection for a corresponding electrode head will now be described, whereat least part of this fabric section is electrically conductive orelectrically dissipative. An electrically conductive portion of a fabricsection is one having an electrical conductivity of at least about 10⁻²S/m in one embodiment. An electrically dissipative portion of a fabricsection is one having an electrical conductivity of at least about 10⁻⁹S/m. Any such fabric section may include the following features,individually or in any appropriate combination: 1) a fabric section maybe defined by one or more threads, where each such thread is acollection of filaments that are twisted together along a lengthdimension of the thread; 2) a fabric section may be defined by one ormore yarns, where each such yarn is a collection of threads that aretwisted together along a length dimension of the yarn; 3) a fabricsection may be defined by threads/yarns of different diameters; 4) afabric section may be defined by threads having different filamentcounts, by yarns having different thread counts, or both; 5) a fabricsection may be formed from any appropriate material or combination ofmaterials; 6) a fabric section may be of any appropriate size, shape,and/or configuration; 7) a fabric section may be in the form of a solidstructure; 8) a fabric section may be in the form of a hollow structure;9) a fabric section may be in the form of an at least substantiallyrigid structure; 10) a fabric section may be in the form of a flexiblestructure; 11) a fabric section may have a modulus of elasticity of nomore than about that of the target tissue (e.g., the myocardial wall) inone embodiment; 12) a fabric section may be in the form of a porousstructure; 13) a fabric section may have a variable porosity dependingon the application, may have a porosity within a range of beingimpervious to a particular fluid used with the electrode head, toproviding such a fluid with an unimpeded flow in one embodiment, orboth; 14) a fabric section may have one or more regions with differentporosities; 15) a fabric section may be used in combination with onemore other layers or sections to define an electrode head; 16) a fabricsection may be integrated with an electrode head and/or configured toprovide a desired electrical field and/or a desired interaction withpatient tissue; 17) a fabric section may provide/accommodate asubstantially constant electrical conductivity along the length of theelectrode head; 18) a fabric section may provide/accommodate a variedelectrical conductivity along the length of the electrode head; 19) afabric section may provide/accommodate a substantially constanthydraulic conductivity along the length of the electrode head; and 20) afabric section may provide/accommodate a varied hydraulic conductivityalong the length of the electrode head. Although these electrode headsare particularly suited for tissue applications, where electrical energyis exchanged between the electrode head and tissue, they may be utilizedby any appropriate electrode and for any appropriate application.

FIG. 1A illustrates one embodiment of what may be characterized as atissue electrode system 10—an electrode system that is intended tomechanically interface or at least electrically couple with tissue.Initially, the tissue electrode system 10 may be operativelyinterconnected with one or more other components, such as a navigationdisplay, an imaging system, an electrical energy source, or the like.The tissue electrode system 10 is illustrated as being in the form of acatheter electrode that may be introduced into a patient's artery orvein at an appropriate location (e.g., the leg, neck, or arm).Additional components may be utilized to direct the tissue electrodesystem 10, more specifically its electrode head 20, to the desiredlocation within the patient's body (e.g., a guidewire or introducer).

The tissue electrode system 10 includes a handle 12 (e.g., disposedoutside of the patient's body), an elongated body 18 (e.g., a catheteror other device, and disposable within a patient's body) that can beattached to the handle 12, and an electrode head 20. Other components ofthe tissue electrode system 10 include a fluid conduit 14 and anelectrical conduit 16. Each of the fluid conduit 14 and the electricalconduit 16 may be of any appropriate size, shape, and/or configuration.Generally, the fluid conduit 14 provides an appropriate fluid to theelectrode head 20 as desired (e.g., through a lumen or the like), whilethe electrical conduit provides an appropriate electrical signal toand/or from the electrode head 20 as desired. Incorporation of the fluidconduit 14 by the tissue electrode system 10 provides a wet electrodeconfiguration. The fluid conduit 14 also may be eliminated, providing adry electrode configuration for the tissue electrode system 10 (notshown).

The electrode head 20 includes at least a fabric section 22, which maybe of any appropriate size, shape, and/or configuration. The entirety ofthe electrode head 20 may be defined by the fabric section 22. Anotheroption is for the fabric section 22 to be disposed about and/or mountedon what may be characterized as an internal core 24. That is, the core24 is optional and is thereby represented by dashed lines in FIG. 1A. Inthe case of the tissue electrode system 10 of FIG. 1A, the core 24 isencased by the fabric section 22. This need not always be the case. FIG.1B illustrates an alternative electrode head 20′ for a tissue electrodesystem 10′, where its fabric section 22′ does not cover a distal endwall 27 of the core 24. Common components between the embodiments ofFIGS. 1A and 1B are identified by the same reference numeral, and thediscussion presented herein is applicable to these components in eachembodiment. Those corresponding components that differ in at least somerespect are identified by a “single prime” designation. Various otherembodiments disclosed herein utilize a core having a distal segment thatis exposed.

The core 24 may: 1) be of any appropriate size, shape, and/orconfiguration; 2) be formed from any appropriate material or combinationof materials; 3) be in the form of a rigid structure or a flexiblestructure; and/or 4) provide any appropriate function or combination offunctions in relation to the electrode head 20/20′. For instance, thecore 24 may provide a mounting structure for the fabric section 22/22′(e.g., for integrating the fabric section 22/22′ with the electrode head20/20′). The core 24 may also be utilized for directing fluid throughthe fabric section 22/22′ for a wet electrode application. One optionwould be for the core 24 to be in the form of a solid structure that issufficiently porous such that a fluid flow directed into the core 24 viathe fluid conduit 14 would pass through the fabric section 22/22′ at adesired flow rate. Another option would be for the core 24 to includeone or more internal fluid conduits 28 (FIG. 1C) that extend to anexternal surface of the core 24, such as its sidewall 26, distal endwall 27, or both. The intersection of a fluid conduit 28 with theexterior of the core 24 defines a port 30. Each port 30 may be of anyappropriate size, shape, and/or configuration. The core 24 may includeany appropriate number of ports 30, and multiple ports 30 may bedisposed in any appropriate arrangement.

FIG. 1D illustrates another variation of the tissue electrode system 10of FIG. 1A. Common components between the embodiments of FIGS. 1A and 1Dare identified by the same reference numeral, and the foregoingdiscussion remains applicable to these components. Those correspondingcomponents that differ in at least some respect are identified by a“double prime” designation. In the case of the tissue electrode system10″ of FIG. 1D, the electrode head 20″ includes a fabric section 22″that cantilevers or extends from what may be characterized as a base 32.This base 32 is appropriately integrated with the body 18, may be of anyappropriate size, shape, and/or configuration, may be formed from anyappropriate material or combination of materials, and as shown in FIG.1E includes one or more fluid conduits or lumens 34 that receive a fluidfrom the fluid conduit 14. Each fluid conduit 34 may be of anyappropriate size, shape, and/or configuration, and multiple fluidconduits may be disposed in any appropriate arrangement.

The tissue electrode systems of the embodiments of FIGS. 1A, 1B, and 1Dare each in the form of catheter electrodes, and each such catheterelectrode may be used to provide any appropriate function or combinationof functions (e.g., tissue ablation; tissue mapping; return electrode).A tissue electrode system whose electrode head incorporates a fabricsection may also be used for external tissue applications, such as inthe case of the patch electrode 40 of FIG. 2. The patch electrode 40includes a fabric section 42, and which may be attached to a patient'sskin at any appropriate location and in any appropriate manner (e.g., byuse of any acceptable adhesive or fastening band). An appropriateelectrical conduit 44 (e.g., a wire or cable) is electricallyinterconnected with this fabric section 42. The patch electrode 40 mayalso be irrigated.

FIGS. 3A-F are directed to various representative configurations ofelectrode heads that utilize at least one fabric section. FIG. 3Aillustrates an electrode head 50 having a single fabric section 52 thatmay be of any appropriate size, shape, and/or configuration. FIG. 3Billustrates an electrode head 54 having a pair of sections or layers 56a, 56 b that are disposed in interfacing relation and each of which maybe of any appropriate size, shape, and/or configuration. At least one ofthe sections 56 a, 56 b may be formed from a fabric that is electricallyconductive or electrically dissipative. The other of these sections 56a, 56 b may also be electrically conductive (to the same extent, to agreater extent, or to a lesser extent), may be electrically dissipative,or may be electrically non-conductive. The other of these sections 56 a,56 b also may be in the form of a fabric, or may be of any otherappropriate form. FIG. 3C illustrates an electrode head 58 having atleast three sections or layers 60 a, 60 b, 60 c that are disposed ininterfacing relation and each of which may be of any appropriate size,shape, and/or configuration. At least one of the sections 60 a, 60 b, 60c may be formed from a fabric that is electrically conductive orelectrically dissipative. The other of these sections 60 a, 60 b, 60 cmay also be electrically conductive (to the same extent, to a greaterextent, or to a lesser extent), dissipative, or non-conductive. Theother of the sections 60 a, 60 b, 60 c also may be in the form of afabric, or may be of any other appropriate form. Generally, any numberof sections or layers may be utilized to define an electrode head, andwhere at least one of these sections or layers is fabric. Althoughadjacent layers may be disposed in interfacing relation, such may not berequired in all instances. Moreover, single or multi-layerconfigurations may exist in any appropriate configuration.

FIG. 3D illustrates an electrode head 62 having at least a fabricsection 64. This fabric section 64 may be a solid structure or may be ahollow structure. The fabric section 64 may be of any appropriate size,shape, and/or configuration. FIG. 3E illustrates an electrode head 66where a single fabric section or layer 68 has been rolled up into an atleast generally cylindrical configuration. Although a space is shownbetween each adjacent pair of wraps, such need not be the case. Finally,FIG. 3F illustrates an electrode head 70 having at least two sections orlayers 72 a, 72 b that have been rolled up into an at least generallycylindrical configuration. Again, although a space is shown between eachadjacent pair of wraps, such need not be the case. At least one of thelayers 72 a, 72 b may be formed from a fabric that is electricallyconductive or electrically dissipative. The other of these sections orlayers 72 a, 72 b may also be electrically conductive (to the sameextent, to a greater extent, or to a lesser extent), may be electricallydissipative, or may be electrically non-conductive. The other of thesesections or layers 72 a, 72 b also may be in the form of a fabric, ormay be of any other appropriate form. Single or multi-layerconfigurations could also be folded into a desired end configuration(e.g., bellows-like).

FIG. 4 illustrates a portion of another embodiment of a tissue electrodesystem 80. The tissue electrode system 80 includes an elongated body 82that may be interconnected with an appropriate handle (e.g., handle 12in FIG. 1A). The body 82 is sufficiently flexible to be directed througha bodily passageway (e.g., a vein or artery). There are a number of ringelectrode elements 84 that are spaced along the length dimension of thebody 82. An electrode head 86 is also provided at the distal end of thebody 82. This electrode head 86 includes a fabric section 88.

FIGS. 5-13 illustrate various embodiments of electrode heads thatincorporate fabric for exchanging electrical energy with patient tissue(e.g., transmitting electrical energy for active electrode applications;receiving electrical energy for passive electrode applications). Each ofthese electrode heads may be utilized by any appropriate tissueelectrode system, and may be adapted as desired/required for thecorresponding tissue electrode system application. For instance, each ofthese electrode heads could be utilized by any of the tissue electrodesystems of FIGS. 1A, 1B, 1D, 2, and 4. Each of these electrode heads maybe used with or without a core (e.g., core 24). The fabric section of agiven electrode head may cover only a portion of the core, or mayenclose at least a portion of the core (e.g., at least generally inaccordance with the tissue electrode 10 of FIG. 1A). It will beappreciated that any feature of any of these electrode heads may be usedby any of the other electrode heads as well, where appropriate.

Certain components are illustrated in relation to each of the electrodeheads of FIGS. 5-13. Each is shown in conjunction with a body 92 havingan outer section 94 and an inner section 96, and the space therebetweenmay be characterized as a lumen. This body 92 has a length dimensionthat extends along a reference axis 98. Although the reference axis 98is illustrated as being linear, the body 92 will typically be flexiblefor being directed through a bodily passageway and as shown in FIG. 4.An electrical conduit 100 of any appropriate type (e.g., a wire orcable) is schematically illustrated and extends along the body 92 forelectrical interconnection with an electrically conductive/dissipativeportion of the relevant electrode head. An arrow 102 indicates adirection of fluid flow between the inner section 96 and outer section94 of the body 92 (e.g., a wet electrode configuration), whilerepresentative fluid flow arrows may be illustrated regarding theexiting of this fluid flow through the electrode head. Any appropriateway of providing a fluid flow to the relevant electrode head may beutilized. Moreover, each of the electrode heads may be utilized withoutany fluid flow (e.g., in a dry electrode configuration).

The tissue electrode system 90 of FIG. 5 includes an electrode head 104that incorporates a fabric section 106. The fabric section 106 again maybe disposed over a core (e.g., core 24 from FIG. 1A, core 114 introducedbelow in relation to FIG. 6A), may be in the form of a hollow structure,or may be in the form of a solid structure. Various other representativeelectrode head configurations that incorporate fabric forcontrolling/affecting the exchange of electrical energy with tissue willnow be addressed in relation to the embodiments of FIGS. 6-13.

The tissue electrode system 110 of FIG. 6A includes an electrode head112. There are two main components of the electrode head 112—a fabricsection 118 and a core 114. Generally, the fabric section 118 isdisposed about the core 114 over only a portion of its length. As such,a tip 116 of the core 114 is exposed. This tip 116 is illustrated ashaving a rounded configuration. Other configurations may be appropriatefor the tip 116 as well. The discussion presented above with regard tothe core 24 is equally applicable to the core 114, and will not berepeated. In accordance with the foregoing, the fabric section 118 couldalso cover the tip 116 of the core 114, and the fabric section 118 couldbe used without the core 114. The length or amount of the core 114 thatis exposed may be modified from that illustrated in FIG. 6A as well.Finally, segments of exposed portions of the core 114 could be spacedalong the reference axis 98 (e.g., by having the fabric section 118 bewrapped about the core 114 at a plurality of locations that are spacedalong the reference axis 98). Each of these permutations is applicableto the various embodiments disclosed herein, with the exception of theFIG. 12A embodiment.

The fabric section 118 used by the electrode head 112 includes what maybe characterized as a plurality of first yarn or thread segments 120that are electrically conductive or electrically dissipative, as well aswhat may be characterized as a plurality of the second yarn or threadsegments 122 that are electrically non-conductive. Generally, thevarious first yarn segments 120 are disposed in one orientation, whilethe various non-conductive second yarn segments 122 are disposed in adifferent orientation. Further in this regard and for the illustratedembodiment, the first yarn segments 120 extend at least generallylinearly or axially along the length dimension of the electrode head 112(e.g., at least generally parallel with the reference axis 98, or so asto define the warp of the fabric section 118), while the non-conductivesecond yarn segments 122 are disposed or wrapped about the referenceaxis 98 and thereby cross or intersect with the first yarn segments 120(e.g., so as to define the weft of the fabric section 118). The variousfirst yarn segments 120 and the various second yarn segments 122 arewoven together to define the fabric section 118 (e.g., illustrated bythe squiggly lines defining the first yarn segments 120).

The tissue electrode system 130 of FIG. 6B is illustrated as a variationof the tissue electrode system 110 of FIG. 6A, although the steppedconfiguration of its electrode head 132 may be used by any of the tissueelectrode systems disclosed herein with the exception of the FIG. 12Aembodiment. There are two main components of the electrode head 132—afabric section 138 and a core 114. The fabric section 138 used by theelectrode head 132 includes what may be characterized as a plurality offirst yarn or thread segments 140 that are electrically conductive orelectrically dissipative (e.g., in accordance with the first yarnsegments 120 discussed above in relation to FIG. 6A), as well as whatmay be characterized as a plurality of the second yarn or threadsegments 142 that are electrically non-conductive (e.g., in accordancewith the second yarn segments 122 discussed above in relation to FIG.6A).

There are two discrete portions of the fabric section 138 and which maybe characterized as electrode segments 144 a and 144 b that are disposedin end-to-end relation. Each of the electrode segments 144 a, 144 bincludes the noted first yarn segments 140 and the second yarn segments142. Generally, the outer diameter of the electrode segment 144 a isdifferent than the outer diameter of the electrode segment 144 b. In theillustrated embodiment, the outer diameter of the electrode segment 144a (the distally disposed portion of the fabric section 138) is smallerthan the outer diameter of the electrode segment 144 b (the proximallydisposed portion of the fabric section 138).

The tissue electrode system 150 of FIG. 7 includes an electrode head 152that in turn incorporates a fabric section 158. Instead of being wrappedaround a core 114, the fabric section 158 is wrapped around itself orwrapped into a desired configuration (cylindrical in the illustratedembodiment, and as indicated by the spiral on the exposed, distal end ofthe electrode head 152). The fabric section 158 used by the electrodehead 152 includes what may be characterized as a plurality of first yarnor thread segments 160 that are electrically conductive or electricallydissipative, as well as what may be characterized as a plurality of thesecond yarn or thread segments 162 that are electrically non-conductive.Generally, the various first yarn segments 160 are disposed in a commonorientation with at least some of the non-conductive second yarnsegments 162 (e.g., disposed in at least generally parallel relation).In this regard, the first yarn segments 160 and some of thenon-conductive second yarn segments 162 extend at least generallylinearly or axially along the length dimension of the electrode head 152(e.g., at least generally parallel with the reference axis 98, or so asto define the warp of the fabric section 158). Furthermore, some of thenon-conductive second yarn segments 162 are disposed or wrapped aboutthe reference axis 98 and thereby cross or intersect with the first yarnsegments 160 and those second yarn segments 162 that are similarlyoriented (e.g., so as to define the weft of the fabric section 158). Thevarious first yarn segments 160 and the various second yarn segments 162are woven together to define the fabric section 158 (e.g., illustratedby the squiggly lines defining the first yarn segments 160). Although apair of non-conductive second yarn segments 162 is illustrated as beingdisposed between adjacent pairs of first yarn segments 160, the commonlyoriented first yarn segments 160 and non-conductive second yarn segments162 may be arranged in any appropriate pattern, for instance to achievea desired electrical field (e.g. the similarly oriented first yarnsegments 160 and second non-conductive yarn segments 162 could bedisposed in alternating relation).

The tissue electrode system 170 of FIG. 8 includes an electrode head172. There are two main components of the electrode head 172—a fabricsection 178 and a core 114. The fabric section 178 used by the electrodehead 172 includes what may be characterized as a plurality of first yarnor thread segments 180 that are electrically conductive or electricallydissipative, as well as what may be characterized as a plurality of thesecond yarn or thread segments 182 that are electrically non-conductive.Generally, the various first yarn segments 180 are disposed in oneorientation, while the various non-conductive second yarn segments 182are disposed in a different orientation. In this regard, the first yarnsegments 180 are disposed or wrapped about the reference axis 98 at oneangle. Furthermore, the non-conductive second yarn segments 182 aredisposed or wrapped about the reference axis 98 at a different anglethan the first yarn segments 180, but still cross or intersect with thefirst yarn segments 180. The fabric section 178 illustrates that a firstset of non-conductive second yarn segments 182 are wrapped about thereference axis 98 at one angle and that a second set of non-conductivesecond yarn segments 182 are wrapped about the reference axis 98 at anopposite angle. This may not be required in all instances. In any case,the various first yarn segments 180 and the various second yarn segments122 are woven together to define the fabric section 178 (e.g.,illustrated by the squiggly lines defining the first yarn segments 180).

The tissue electrode system 190 of FIG. 9A includes an electrode head192 that in turn incorporates an electrically conductive or electricallydissipative fabric section or layer 198 and an electricallynon-conductive section or layer 204. The fabric section 198 andnon-conductive section 204 are disposed in interfacing relation andwrapped together into a desired configuration (at least generallycylindrical in the illustrated embodiment), with the fabric section 198defining an exterior sidewall surface for the electrode head 192. Statedanother way, the radially outermost portion of the fabric section 198 isdisposed radially outwardly from the radially outermost portion of thenon-conductive section 204, where a distance in the radial dimension ismeasured from the reference axis 98. Although the non-conductive section204 may be in the form of a fabric, the non-conductive section 204 maybe formed from any appropriate type of non-conductive material orcombination of materials, and may be of any appropriate form orconstruction.

The tissue electrode system 210 of FIG. 9B includes an electrode head212 that in turn incorporates a plurality of concentrically disposedannular sections or layers 214 a-e. Adjacent pairs of the annularsections 214 a-e are disposed in interfacing relation in the illustratedembodiment, although a standoff could be disposed between at least oneof the adjacent pairs of the annular sections 214 a-e at one or morelocations along the reference axis 98. At least one of the annularsections 214 a-e is in the form of an electrically conductive orelectrically dissipative fabric. Any number of the annular sections 214a-e could be in the form of an electrically conductive or electricallydissipative fabric. One or more of the annular sections 214 a-e couldalso be in the form of an electrically non-conductive material (e.g.,fabric). Any arrangement of electrically conductive/dissipative fabricand electrically non-conductive materials could be used for the variousannular sections 214 a-e.

The tissue electrode system 220 of FIG. 10 includes an electrode head222. There are two main components of the electrode head 222—a fabricsection 224 and a core 114. Generally, the electrical conductivity ofthe fabric section 224, the hydraulic conductivity of the fabric section224, or both, is graded or changes proceeding along the reference axis98. In one embodiment, the electrical conductivity of the fabric section224 decreases proceeding in the direction of the arrow A (andgraphically depicted by the density of the shading provided for thefabric section 224). This variation of the electrical conductivity ofthe fabric section 224 may be realized in any appropriate manner. Forinstance, the porosity of the fabric section 224 may change proceedingalong the reference axis 98. Threads of different filament count, yarnsof different thread count, or both may be used to define the fabricsection 224 and achieve the conductivity gradient as well. Similarly,the noted variation of the hydraulic conductivity of the fabric section224 may be realized in any appropriate manner as well. A gradedhydraulic conductivity may be achieved by modifying the porosity of theelectrode head 222 and/or incorporating an anisotropically conductivefabric into the electrode head 222.

The tissue electrode system 230 of FIG. 11A includes an electrode head232. There are two main components of the electrode head 232—anelectrically conductive or electrically dissipative fabric section orelectrode segment 238 and an electrically non-conductive section orelectrode segment 242 that are disposed in end-to-end relation. Althoughthe non-conductive section 242 may be in the form of a fabric, thenon-conductive section 242 may be formed from any appropriate type ofnon-conductive material or combination of materials, and may be of anyappropriate form or construction. In any case, the non-conductivesection 242 is distally disposed in relation to the fabric section 238.In the illustrated embodiment, a distal end 244 of the electrode head232 is defined by the non-conductive section 242. Stated another way,the non-conductive section 242 defines a distal tip of the electrodehead 232 in the illustrated embodiment. Although the non-conductivesection 242 could be in the form of a solid structure to define a soliddistal end 244, the non-conductive section 242 could be defined by awrapped configuration at least generally in accordance with theforegoing (e.g., to provide a distal end 244 have the type ofconfiguration illustrated in FIG. 7).

The distally disposed non-conductive section 242 provides a standoffbetween the target tissue and the fabric section 238 in the case of theelectrode head 232 of FIG. 11A. A conductive fluid may be directed tothe electrode head 232 as noted above (e.g., through a flow path betweenthe outer section 94 and inner section 96 of the body 92, and at leastgenerally in the direction indicated by the arrow 102). This conductivefluid may carry a current from the fabric section 238 of the electrodehead 232 to the target tissue, thereby creating the effect of a virtualelectrode.

The tissue electrode system 250 of FIG. 11B includes an electrode head252. There are two main components of the electrode head 252—anelectrically conductive or dissipative fabric section or electrodesegment 258 and an electrically non-conductive section or electrodesegment 262 that are disposed an end-to-end relation. Although thenon-conductive section 262 may be in the form of a fabric, thenon-conductive section 262 may be formed from any appropriate type ofnon-conductive material or combination of materials, and may be of anyappropriate form or construction. In any case, the fabric section 258 isdistally disposed in relation to the non-conductive section 262. In theillustrated embodiment, a distal end 264 of the electrode head 252 isdefined by the fabric section 258, and is only schematically illustratedin FIG. 11B. This distal end 264 could be at least generally inaccordance with the distal end shown in FIG. 7, or could be in the formof an appropriately shaped distal end of a core with the fabric section258 being disposed thereabout. It should be appreciated that the fabricsection 258 may also be characterized as defining a distal tip of theelectrode head 232 in the illustrated embodiment.

The tissue electrode system 270 of FIGS. 12A-B includes an electrodehead 272. There are two main components of the electrode head 272—a base280 and a plurality of electrode segments 278 that extend from the base280. Generally, the electrode segments 278 are each in the form of acantilever, having a fixed end (e.g., at the base 280) and adistally-disposed free end. At least some of the electrode segments 278are disposed in different orientations. This is subject to a number ofcharacterizations. One is that at least some of the electrode segments278 are disposed in non-parallel relation. Another is that at least someof the electrode segments diverge relative to the reference axis 98proceeding from the base 280 toward their respective distal end. Anotheris that the plurality of electrode segments 278 collectively define asplayed configuration.

Although the electrode segments 278 could be formed from any appropriatematerial, in one embodiment each of the electrode segments 278 includesor are defined by an electrically conductive or electrically dissipativefabric. The electrode segments 278 may be of any appropriate size,shape, and/or configuration. For instance, each electrode segment 278could be in the form of a single thread segment or a single yarnsegment, for instance in accordance with FIGS. 12A-B. Another optionwould be for each of the fabric sections 278 to be in the form of afabric section, such as the fabric sections 278a illustrated in FIG.12C.

The various electrode segments 278 may be disposed in any appropriatearrangement. Each of the various electrode segments 278 may be equallyspaced from each other. Two or more different spacings between adjacentelectrode segments 278 may be utilized as well. In one embodiment, theelectrode head 292 utilizes an at least substantially constant densityfor the various electrode segments 278. Another embodiment utilizes avaried density for the various electrode segments 278.

The tissue electrode system 290 of FIG. 13 includes an electrode head292, that in turn includes an electrically conductive or electricallydissipative fabric section 298. The electrode head 292 further includesone or more sensors 300. Three sensors 300 are illustrated in relationto the electrode head 292, although any number of sensors 300 may beutilized and may be disposed at any appropriate location. Each sensor300 may be of any appropriate size, shape, configuration, and/or type,and furthermore may provide any appropriate function or combination offunctions. For instance, a sensor 300 may be provided to monitortemperature (e.g., an electrode head-tissue interface temperature), asensor 300 may be provided to monitor pressure (e.g., a pressure beingexerted by the electrode head 292 on the tissue), or a sensor 300 may beused for situ lesion identification and characterization (e.g., usingfiber optics, ultrasound, or both). One or more of these sensors 300 maybe utilized by any of the electrode heads disclosed herein.

The electrode heads described herein may be used with any appropriatetype of electrode. For instance, each of these electrode heads may beintegrated with a catheter electrode. Another option is for each ofthese electrode heads to be used by a ground patch or the like thatinterfaces with the patient's skin (e.g., interfaces with an exteriorsurface of the patient). Each such electrode head may also provide anyappropriate function or combination of functions. One embodiment has theelectrode head providing an active function, such as tissue ablation ortissue mapping. Another embodiment has the electrode head configured fora passive function, such as for use by a return electrode. Eachelectrode head may direct electrical energy to a single location (e.g.,for spot tissue ablation), or may apply electrical energy to tissuewhile being moved relative to the tissue (e.g., to create a linearlesion).

Each of the electrode heads disclosed herein may be used in a dryelectrode configuration, or alternatively in a wet electrodeconfiguration. With regard to a wet electrode configuration, anyappropriate fluid may be utilized. In one embodiment, the fluid iselectrically conductive. Representative fluids for a wet electrodeconfiguration include without limitation saline, radioopaque solutions,and liquid drugs. Any appropriate flow rate may be provided to any ofthe electrode heads disclosed herein as well. In one embodiment, a flowrate of no more than about 30 ml/minute may be provided to any of theelectrode heads disclosed herein, and which may be suitable based uponthe use of one or more fabric sections.

Although various embodiments of this invention have been described abovewith a certain degree of particularity, those skilled in the art couldmake numerous alterations to the disclosed embodiments without departingfrom the spirit or scope of this invention. All directional references(e.g., upper, lower, upward, downward, left, right, leftward, rightward,top, bottom, above, below, vertical, horizontal, clockwise, andcounterclockwise) are only used for identification purposes to aid thereader's understanding of the present invention, and do not createlimitations, particularly as to the position, orientation, or use of theinvention. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each otherunless otherwise noted. It is intended that all matter contained in theabove description or shown in the accompanying drawings shall beinterpreted as illustrative only and not limiting. Changes in detail orstructure may be made without departing from the spirit of the inventionas defined in the appended claims.

1.-20. (canceled)
 21. A tissue electrode system, comprising: anelongated catheter body having a distal end adapted for dispositionwithin a patient body; a generally cylindrical fabric electrode formedof woven threads attached to said distal end of said elongated catheterbody, wherein at least a portion of said woven threads are electricallyconductive and electrically connectable with an electrical energysource, said fabric electrode including: a first segment having a firstlevel of electrical conductivity; and a second segment axially disposedrelative to said first segment in a length dimension of said generallycylindrical fabric electrode and having a second level of electricalconductivity different than said first level of electrical conductivity.22. The tissue electrode system of claim 21, wherein said first level ofelectrical conductivity is one of electrically conductive andelectrically dissipative and said second level of electricalconductivity is electrically non-conductive.
 23. The tissue electrodesystem of claim 22, herein said first level of electrical conductivitycomprises an electrical conductivity of greater than 10⁻⁹ S/m (Siemensper meter) and said second level of electrical conductivity comprises anelectrical conductivity of less than 10⁻⁹ S/m.
 24. The tissue electrodesystem of claim 21, wherein said first segment is disposed distallyrelative to said second segment.
 25. The tissue electrode system ofclaim 21, wherein said second segment is disposed distally relative tosaid first segment.
 26. The tissue electrode system of claim 21, whereinsaid first segment and said second segment are disposed in an end-to endrelation.
 27. The tissue electrode system of claim 21, wherein saidgenerally cylindrical fabric electrode cantilevers from said distal endof said elongated catheter body free of internal support.
 28. The tissueelectrode system of claim 27, wherein said elongated catheter bodyfurther comprises: at least a first fluid conduit extending through aportion of said elongated catheter body and exiting through said distalend of said elongated catheter body.
 29. The tissue electrode system ofclaim 28, wherein said woven threads are porous to permit fluid fromsaid first fluid conduit to pass into and through said generallycylindrical fabric electrode.
 30. The tissue electrode system of claim29, wherein an entirety of a proximal peripheral edge of said generallycylindrical fabric electrode is fixedly attached to said distal end ofsaid elongated catheter body and around said first fluid conduit. 31.The tissue electrode system of claim 21, wherein said generallycylindrical fabric electrode further comprises multiple layers offabric.
 32. The tissue electrode system of claim 21, wherein: said firstsegment of said fabric electrode comprises a first substantiallycylindrical fabric layer; and said second segment of said fabricelectrode comprises a second substantially cylindrical fabric layer,wherein said second substantially cylindrical fabric layer is at leastpartially disposed within an interior of said first substantiallycylindrical fabric layer.
 33. The tissue electrode system of claim 21further comprising: a core extending from said distal end of saidelongated catheter body, wherein said core is disposed within aninterior of said generally cylindrical fabric electrode.
 34. The tissueelectrode system of claim 33, wherein said core further comprises: aninternal conduit connected to a fluid conduit extending through aportion of said elongated catheter body.
 35. The tissue electrode systemof claim 34, wherein said core has a porous length disposed within theinterior of said generally cylindrical fabric electrode.
 36. The tissueelectrode system of claim 35, wherein said porous length comprises aplurality of fluid ports extending between said internal conduit and anoutside surface of said core.
 37. The tissue electrode system of claim21, further comprising: a plurality of said second segments attached tosaid first segment.
 38. The tissue electrode system of claim 21, whereineach of said plurality of second segments cantilever from a distal endof said first segment.
 39. The tissue electrode system of claim 21,wherein said first segment has a first diameter and said second segmenthas a second diameter, wherein said first and second diameter aredifferent.
 40. The tissue electrode system of claim 39, wherein saidsecond segment is distally disposed to said first segment and saidsecond diameter is less than said first diameter.